JP7116151B2 - Systems for lesion formation and assessment - Google Patents

Description

[Related Application]
No. 14/919,004, filed Oct. 21, 2015.
and U.S. Provisional Application No. 62/194,276, filed July 19, 2015, both of which are hereby incorporated by reference in their entireties.

[Technical field]
TECHNICAL FIELD This disclosure relates generally to catheters, and more specifically to ablation and visualization catheters.

Atrial fibrillation (AF) is currently the most common sustained arrhythmia in the world, affecting millions of people. By 2050, it is predicted that 10 million people will be affected by AF in the United States. AF is an independent risk factor for stroke, with increased mortality and morbidity and worsened quality of life. The substantial lifetime risk of developing AF highlights the health insurance burden of the disease, resulting in annual treatment costs of over $7 billion in the United States alone.

It is known that most of the symptoms in AF patients are triggered by local electrical activity originating within the muscular sleeve extending into the pulmonary vein (PV). Atrial fibrillation may also be triggered by local activity within the superior vena cava or other atrial structures, ie, other cardiac tissue within the heart's conduction system. These local triggers can give rise to atrial tachycardia caused by reentrant electrical activity (or rotors), followed by the numerous electrical wavelets that characterize atrial fibrillation. It may be subdivided. In addition, prolonged AF can alter the function of the heart cell membrane, which further sustains atrial fibrillation.

Radiofrequency ablation (RFA), laser ablation, and cryoablation are the most common techniques of catheter-based mapping and ablation systems used by physicians to treat atrial fibrillation. . Physicians use catheters to direct energy to create electrical isolation lines that destroy local triggers or isolate them from the heart's other conductive systems. The latter technique is commonly used for what is called pulmonary vein isolation (PVI). However, the success rate of AF ablation procedures remains rather stagnant, with recurrence prediction rates as high as 30%-50% one year after surgery. The most common reason for recurrence after catheter ablation is 1
one or more gaps. Usually this gap is an ineffective or incomplete lesion.
). This damage temporarily blocks the electrical signal during the procedure, but over time it may stop blocking and prompt recurrence of atrial fibrillation.

Accordingly, there is a need for systems and methods for forming and validating adequate lesions to improve post-operative outcomes and reduce costs.

According to some aspects of the present disclosure, a catheter for visualizing ablated tissue is provided. The catheter comprises a catheter body, a distal end member (distal tip) disposed at the distal end of the catheter body and defining an illumination cavity, and a light directing member disposed within the illumination cavity. . The distal end member has one or more openings for exchanging light energy between the illumination cavity and tissue. The light directing member is configured to direct light energy to and from tissue through one or more openings in the distal end member.

In some embodiments, the distal end member of the catheter can be configured to deliver ablation energy to tissue. Ablation energy is from the group consisting of radio frequency (RF) energy, microwave energy, electrical energy, electromagnetic energy, cryoenergy, laser energy, ultrasonic energy, acoustic energy, chemical energy, thermal energy and combinations thereof. selected.

In some embodiments, the light directing member and the one or more openings are configured to illuminate tissue radially and axially relative to the longitudinal axis of the catheter. In some embodiments, the one or more openings are disposed along the sidewall of the distal end member and the light directing member is configured (shaped) to split the light, specifically In terms of
Shaped to direct light energy through one or more openings at an angle to the longitudinal axis of the catheter. In some embodiments, the light directing member comprises one or more through-holes and the distal end member comprises one or more openings disposed in the front wall of the distal end member, wherein the light is It can pass longitudinally through one or more openings in the guide member and the front wall. In some embodiments, the catheter may further comprise an ultrasound transducer.

According to some aspects of the present disclosure, a system for visualizing ablated tissue is provided. The system includes a catheter, a light source, a light meter, and one or more optical fibers in communication with the light source and light meter. The catheter includes a catheter body and
A distal end member disposed at the distal end of the catheter body defining an illumination cavity, and a light directing member disposed within the illumination cavity. The distal end member has one or more openings for exchanging light energy between the illumination cavity and tissue. The light directing member is configured to direct light energy to and from tissue through one or more openings in the distal end member. One or more optical fibers extend through the catheter body and into the illumination cavity of the distal end member. One or more optical fibers are configured to direct light energy from the light source to the light directing member to illuminate tissue outside the distal end member. One or more optical fibers are configured to relay optical energy reflected from the tissue to the optical meter.

According to some aspects of the present disclosure, a method of visualizing ablated tissue is provided. The method includes a catheter body and one or more distal end members disposed at the distal end of the catheter body and defining an illumination cavity for exchanging light between the illumination cavity and tissue. a distal end member having an opening and a light directing member disposed within the illumination cavity to direct light to tissue through one or more openings in the distal end member; ,
a light directing member configured to direct light from the tissue; advancing a catheter to heart tissue in need of ablation; directing light to the light directing member through one or more openings in the distal end member of the catheter to excite nicotinamide adenine dinucleotide hydrogen (NADH) in the region of collecting light reflected from the heart tissue through one or more apertures and directing this collected light to a photometer; and generating a representation of the imaged and illuminated (illuminated) cardiac tissue. The display shows ablated heart tissue as exhibiting less fluorescence than non-ablated heart tissue.

In some embodiments, the method includes ablating tissue with a distal end member prior to imaging the tissue, and measuring the amount of fluorescence between the ablated and non-ablated cardiac tissue. ablating another non-ablated cardiac tissue identified by the discriminating based.

The embodiments disclosed herein will be further described with reference to the accompanying drawings, in which like structures are referenced with like numerals throughout the several figures. The drawings shown are not necessarily to scale, emphasis instead generally being on explaining the principles of the embodiments disclosed herein.

1 is one embodiment of an ablation visualization system of the present disclosure; 1 is a diagram of a visualization system used in connection with the ablation visualization system of the present disclosure; FIG. 1 shows one embodiment of a distal end member of a catheter of the present disclosure; 1 shows one embodiment of a light directing member of a catheter of the present disclosure; 1 shows one embodiment of a light directing member of a catheter of the present disclosure; 1 shows one embodiment of a distal end member of a catheter of the present disclosure; 1 shows one embodiment of a distal end member of a catheter of the present disclosure; Fig. 3 shows a fiber optic alignment member of the catheter of the present disclosure; Fig. 3 shows a fiber optic alignment member of the catheter of the present disclosure; Fig. 3 shows a fiber optic alignment member of the catheter of the present disclosure; Fig. 3 shows a fiber optic alignment member of the catheter of the present disclosure; 1 illustrates one embodiment of a light directing member of the present disclosure; 1 illustrates one embodiment of a light directing member of the present disclosure; 4A and 4B show various embodiments of catheters of the present disclosure; 4A and 4B show various embodiments of catheters of the present disclosure; 4A and 4B show various embodiments of catheters of the present disclosure; 4A and 4B show various embodiments of catheters of the present disclosure; 1 illustrates one embodiment of a catheter of the present disclosure that illuminates a fluorescent solution; 4 is a flow chart of a method of using the system of the present disclosure;

While the drawings identified above illustrate embodiments disclosed herein, other embodiments are possible, as noted in the description. This disclosure presents illustrative embodiments by way of representation and not limitation. Those skilled in the art can devise numerous other modifications and embodiments without departing from the scope and spirit of the principles of the embodiments disclosed herein.

The present disclosure relates generally to systems and methods for applying radio frequency (radio frequency), laser, or cryoablation energy to the body to create therapeutic lesions. In some embodiments, nicotinamide adenine dinucleotide hydrogen (NADH) fluorescence (fN
ADH) can be used to image tissue using the disclosed systems and methods. As a non-limiting example, the systems and methods may be used during treatment of atrial fibrillation (AF).

Generally, the system may include a catheter with optics for exchanging light between tissue and the catheter. In some embodiments, the system allows direct visualization of tissue NADH fluorescence (NADH fluorescence emission), or lack thereof, induced by ultraviolet (UV) excitation. The fluorescence signature returned from the tissue is used to determine whether there is ablation damage within the illuminated (irradiated) tissue and to determine information about the damage occurring during ablation. can be This optical tissue probing can be performed on a variety of tissue types, including heart tissue, endocardial tissue, epicardial tissue, myocardial tissue, valves, vascular structures, and fiber and anatomy. academic structure, but
It is not limited to these. The systems and methods of the present disclosure can be used to analyze tissue architecture (composition) including, but not limited to, the presence of collagen and elastin. However, the methods and systems disclosed herein may also be applicable to analyzing damage in other tissue types. The lesion analyzed can be created by applying ablation energy during an ablation procedure. In some embodiments, pre-existing lesions created by ablation or other means may be analyzed using the methods and systems disclosed herein.

Referring to FIG. 1, a system 100 for performing ablation therapy may comprise an ablation therapy system 110, a visualization system 120, and a catheter 140. FIG. In some embodiments, system 100 may also include irrigation system 170 . The system may also have a display 180 . Display 180 may be a separate display, as described below, or
It may be part of visualization system 120 .

In some embodiments, ablation therapy system 110 is designed to deliver ablation energy to catheter 140 . Ablation treatment system 1
10 may comprise one or more energy sources. The energy source is radiofrequency
: RF) energy, microwave energy, electrical energy, electromagnetic energy, cryoenergy, laser energy, ultrasonic energy, acoustic energy, chemical energy, thermal energy, or used to ablate tissue. Can generate any other type of energy possible. In some embodiments, the system includes an RF generator, an irrigation pump 170, an irrigated-tip
It includes an ablation catheter 140 and a visualization system 120 .

Referring to FIG. 2, visualization system 120 may comprise light source 122 , light meter 124 , and computer system 126 .

In some embodiments, light source 122 has an output wavelength within the absorption range of a target fluorophore (NADH in some embodiments) to induce fluorescence emission in healthy myocardial cells. can. In some embodiments, light source 122 is a solid state laser capable of producing UV light to excite NADH fluorescence. In some embodiments, the wavelength can be about 355 nm or 355 nm±30 nm. In some embodiments, light source 12
2 can be a UV laser. Laser-generated UV light may provide much more power for irradiation and, as used in some embodiments of catheters,
It may be more efficiently combined with a fiber-based illumination system. In some embodiments, the system can use lasers with adjustable power up to 150 mW.

The wavelength range of the light source 122 may be limited by the subject's anatomy,
The user may specifically select a wavelength that produces maximal NADH fluorescence without exciting excessive fluorescence of collagen, which exhibits an absorption peak only at slightly shorter wavelengths. In some embodiments, the wavelength of light source 122 is between 300 nm and 400 nm. In some embodiments, the wavelength of light source 122 is between 330 nm and 370 nm. In some embodiments, the wavelength of light source 122 is between 330 nm and 355 nm. In some embodiments, narrow band 35
A 5 nm light source may be used. The output power of light source 122 may be high enough to produce a recoverable tissue fluorescence signature, but not high enough to induce cell damage. A light source 122 may be connected to the optical fiber to provide light to the catheter 140, as described below.

In some embodiments, the system of the present disclosure may use a spectrometer as the light measuring instrument 124 . In some embodiments, light meter 124 may comprise a camera connected to computer system 126 for analyzing and observing tissue fluorescence. In some embodiments, the camera can have high quantum efficiency for wavelengths corresponding to NADH fluorescence. One such camera is Andor's iXon DV860. Spectrometer 124 may be connected to an imaging bundle that may extend into catheter 140 to visualize tissue. In some embodiments, an imaging bundle for spectroscopy and an optical fiber for illumination may be combined. An optical bandpass filter (optical bandpass filter) in the range 435 nm to 485 nm (460 nm in some embodiments) is inserted between the imaging bundle and the camera to block light outside the NADH fluorescence emission band. can be In some embodiments, another optical bandpass filter is inserted between the imaging bundle and the camera to block light outside the NADH fluorescence emission band selected according to the peak fluorescence of the tissue being imaged. obtain.

In some embodiments, light meter 124 may be a CCD (charge coupled device) camera. In some embodiments, the spectrometer 124 may be chosen to collect as many photons as possible and to minimize noise in the image. Normally, for live-cell fluorescence imaging, a CCD camera should have a quantum efficiency of at least between 50-70% at about 460 nm, which indicates that 30-50% of the photons are ignored. In some embodiments, the camera has a quantum efficiency of about 90% at 460nm. The camera may have a sample rate of 80KHz. In some embodiments, spectrometer 124 may have a readout noise of 8e-(electrons) or less. In some embodiments, spectrometer 124 has a minimum readout noise of 3e-. other light measuring instruments,
It may be used in the systems and methods of the present disclosure.

An optical fiber 150 can send the collected light to a longpass filter that blocks the reflected excitation wavelength of 355 nm, but the fluorescence emitted from the tissue at wavelengths above the cutoff of the filter. let it pass. Filtered light from tissue can then be captured and analyzed with a sensitive spectrometer 124 . Computer system 126 obtains information from spectrometer 124 and displays it to the physician. Computer 126 may also provide some additional functions, including control of light source 122, control of spectrometer 124, and execution of application-specific software.

In some embodiments, digital images generated by analyzing optical data are used to perform 2D (two-dimensional) and 3D (three-dimensional) reconstruction of lesions, which can be used to determine size, shape, and , may indicate any other features required for analysis. In some embodiments, an imaging bundle may be connected to spectrometer 124 . Spectrometer 124 may produce a digital image of the lesion studied from NADH fluorescence (fNADH), displayable on display 180 . In some embodiments, this image can be displayed to the user in real time. This image is analyzed with software to obtain real-time details (e.g., intensity or radiant energy at specific regions of the image) for the user to determine if additional therapeutic intervention is necessary or desirable. It is also possible to help In some embodiments, NADH fluorescence can be sent directly to computer system 126 .

In some embodiments, analysis of optical data acquired with a photometer during and after ablation can provide information regarding damage. This damage information includes, but is not limited to, damage depth and damage size. In some embodiments, the data from the optical meter is analyzed to determine whether the catheter 140 is in contact with the myocardial surface and how much pressure is applied to the myocardial surface by the tip of the catheter. It is possible to determine whether In some embodiments, data from spectrometer 124 is analyzed to determine the presence of collagen or elastin in tissue. In some embodiments, data from the optical meter is analyzed to provide the user with real-time feedback on damage progression, damage quality, contact with the myocardium, tissue collagen content, and tissue elastin content. The user is visually shown via a graphical user interface to do so.

In some embodiments, system 100 of the present disclosure may further comprise ultrasound system 190 . Catheter 140 may include an ultrasound transducer that communicates with an ultrasound system. In some embodiments, ultrasound can indicate tissue depth, which in combination with metabolic activity or depth of injury can categorically indicate that the injury is actually transmural. can be used to determine whether In some embodiments, catheter 140 may include position or navigation sensors in communication with location or navigation system 200, as described below.

Referring again to FIG. 1, catheter 140 includes catheter body 142 having proximal end 144 and distal end 146 . Catheter body 142 may be made of a biocompatible material and may be sufficiently flexible to allow guidance and advancement of catheter 140 to the ablation site. In some embodiments, the catheter body 142 can have regions of varying stiffness. For example, the stiffness of catheter 140 may increase from proximal end 144 to distal end 146 . In some embodiments, the stiffness of catheter body 142 is selected to enable delivery of catheter 140 to a desired heart location. In some embodiments, the catheter 140 is a steerable irrigation radio frequency (RF)
It can be an ablation catheter. The catheter can be delivered through the sheath to the endocardial space by standard transseptal procedures using access tools common to the left side of the heart. Catheter 140 may include handle 147 at proximal end 144 . Handle 147 may communicate with one or more lumens of catheter 140 so that instruments or materials may be passed through catheter 140 . In some embodiments, the handle 147 may include connections for standard RF generators and irrigation systems for treatment. In some embodiments, catheter 140 may also include one or more adapters configured to accommodate optical fibers 150 for illumination and spectroscopy.

Referring to FIG. 3, catheter 140 may include a distal end member (distal tip) 148 at distal end 146 having a side wall 156 and a front wall 158 . The front wall 158 can be flat, conical, or domed, for example. In some embodiments, distal end member 1
48 may be configured to function as an electrode for diagnostic purposes, such as electrogram sensing, therapeutic purposes, such as for emitting ablative energy, or both. In some embodiments where ablation energy is required, distal end member 148 of catheter 140 may function as an ablation electrode or ablation element.

In embodiments in which RF energy is provided, wiring can be passed through the lumen of the catheter to connect the distal end member 148 to a source of RF energy (external to the catheter). Distal end member 148 may include ports that communicate with one or more lumens of the catheter. Distal end member 1
48 can be made from any biocompatible material. In some embodiments, distal end member 1
When 48 is configured to function as an electrode, distal end member 148 is made of metal including, but not limited to, platinum, platinum-iridium, stainless steel, titanium, or similar materials. obtain.

Referring to FIG. 3, a fiber optic or imaging bundle 150 may pass from visualization system 120 through catheter body 142 and into illumination cavity or section 152 defined by distal end member 148 . Distal end member 148 may be provided with one or more openings 154 for exchanging light energy between illumination cavity 152 and tissue. In some embodiments, the presence of multiple openings 154 does not impair the function of distal end member 148 as an ablation electrode. This light is transmitted by fiber 150 to distal end member 148 .
to illuminate tissue near distal end member 148 (irradiate tissue near distal end member 148). This illuminating light is either reflected or causes the tissue to fluoresce. Light reflected by and fluorescently emitted from tissue passes through optical fiber 15 within distal end member 148 .
0 and returned to visualization system 120 . In some embodiments, the same optical fiber is used to direct light to light directing member 160 to illuminate tissue outside catheter 140 in one or more directions and to collect light from the tissue. Or a fiber bundle 150 can be used.

In some embodiments, one or more openings 154 are formed in sidewalls 156 of distal end member 148 .
, the front wall 158, or both. In some embodiments, the one or more openings 154 may be circumferentially (circumferentially) disposed along the distal end member 148 all the way around the distal end member 148 . In some embodiments, one or more openings 154 may be disposed equidistant from each other. The number of openings can be determined by the desired viewing angle range. For example, 3
In the case of two equidistant apertures, irradiating light and returning light occur in units of 120 degrees (360 degrees divided by 3). In some embodiments, one or more openings 154 are formed in sidewall 15 of distal end member 148 .
6 may be provided in multiple rows. In some embodiments, the distal end member 148 is
6 may be provided with three or four openings. In some embodiments, a single opening may be provided in the center of front wall 158 . In some embodiments, a plurality of openings 154 in front wall 158
can be provided. In some embodiments, the distal end member 148 has three side openings and one side opening.
Two front openings are provided. One or more openings 154 may also serve as irrigation ports to connect with an irrigation system. In some embodiments, light is directed only through some side openings 154 . For example, in some embodiments sidewall 15
If there are 6 openings in 6, light guidance is only from 3 openings, other openings can be used for irrigation (irrigation, washing).

Light guiding into illumination cavity 152 to enable exchange of light energy between illumination cavity 152 and tissue via multiple paths (axially and radially with respect to the central longitudinal axis of the catheter). A member 160 may be provided. Light directing member 160 may direct illuminating light to tissue and may direct light returned through one or more openings 154 in distal end member 148 to optical fiber 150 . Light directing member 160 may be made from any biocompatible material that reflects light or has a surface that can be altered to reflect light. This material can be, for example, stainless steel, platinum, platinum alloys, quartz, sapphire, fused silica, metallized plastic, or other similar material. In some embodiments, the light directing member 160
may comprise highly polished mirrors. Light directing member 160 may be conical (ie, smooth) or multi-sided (faceted) with any number of sides. Light directing member 160 may be formed (shaped) to bend light at any desired angle. In some embodiments, light directing member 160 may be formed (shaped) to reflect light only through one or more openings. In some embodiments, the material of light directing member 160 is selected from materials that do not fluoresce when exposed to radiation between 310 nm and 370 nm.

In some embodiments, as shown in FIG. 3, the light directing member 160 can include one or more holes 162 through the centerline of the mirror, thereby allowing illuminating and reflected light to pass through. Light can pass straight axially along the catheter 140 in both directions. Such an axial path may be useful when the distal-most surface of distal end member 148 is in contact with body tissue. An alternative radial path is for the distal-most surface of distal end member 148 to be pushed by anatomy, as is sometimes the case in a patient's left atrium during pulmonary vein isolation procedures common in the treatment of atrial fibrillation. It can be useful when the target site cannot be accessed. In some embodiments, since the light passes through the cooling fluid, which is often saline, all paths may not require lens effects and the optics may be compatible with the irrigation system 170. .
The irrigation system 170 also serves to flush blood from the holes 162, thereby keeping the optics clean.

Referring to FIG. 4A, light directing member 160 includes a plurality of angled facets (facets) 16
can have a front surface 164 with 6; In some embodiments, the light directing member 160 may comprise 3 or 4 equidistant facets, although more or less facets may be used. In some embodiments, the number of facets 166 may match the number of openings 154 in sidewall 156 . In some embodiments, the number of facets 166 may be less than the number of openings 154 in sidewalls 156 . In some embodiments, facets 166 may be positioned at 45 degrees to the central axis of light directing member 160 (135 degrees to the axis of the catheter), as shown in FIG. 4B. In some embodiments, facet 16
6 can be placed at an angle greater or less than 45 degrees to direct the light more distally or more proximally.

Referring to FIG. 5A, light directed from optical fiber 150 onto light guide member 160 may be reflected by light guide member 160 . A portion of the reflected light may exit distal end member 148 through one or more openings 154 in side walls 156 of distal end member 148 . The light directing member is specifically directable to separate or split a light beam striking the light directing member into a plurality of beams and to exit the split beams through corresponding openings 154 . In this way, the intensity of the light from the light source can be substantially conserved and the intensity of illumination of the tissue can be increased. on the other hand,
If the light directing member does not focus the light into the aperture 154, and the light diffuses through the illumination cavity, the intensity of the light illuminating the tissue (the light directed at the tissue) may be insufficient for tissue imaging. Further, in some embodiments, the light directing member is configured to collect the light beam reflected from the tissue and direct it to an optical fiber, which relays the light beam to the light meter. be able to. In some embodiments, beams received from tissue may be combined prior to being sent to an optical fiber. In some embodiments, all light directed into the illumination cavity is directed by a light directing member to exit illumination cavity 15 through opening 154.
2 can be emitted. Additionally, the hole 162 of the light directing member 160 and the front wall 15 of the distal end member 148
8 apertures 154 also allow light to pass through. By aligning the light directing member 160, the optical fiber 150 and the aperture 154, the intensity of light to the tissue can be adjusted and maximized. By adjusting and optimizing the angle of the facets 166, the size, number and location of the openings 154 and the size, number and location of the holes in the light guide member 160, the catheter can pass through the openings in the light guide member 160. A desired balance of return light from tissue irradiated at the distal end member 148 of and through the opening 154 may be provided.

As shown in FIG. 5B, in some embodiments, openings 154 may be aligned with facets 166 of light directing member 160 . In some embodiments, the correspondence between openings 154 and facets 166 may differ from 1:1. In some embodiments, catheter 1
40 may comprise three or four openings corresponding to the three or four facets 166 of the light directing member 160, respectively. In some embodiments, some openings 154 may not be used for light exchange due to the shape and orientation of openings 154 and light guide members 160, and may only be used for irrigation. Note that it is not As shown in FIG. 5B, openings 154a may be aligned with facets 166 for optical exchange, while openings 154b are not aligned with facets 166. FIG. Therefore, aperture 154b is primarily used for irrigation even when exchanging additional light.

6A and 6B, in some embodiments, a fiber alignment member (fiber aligner) 168 is provided on the distal end member to align (align) the optical fiber 150 with the light directing member 160 . 148. Fiber alignment member 16
8 may include a fiber lumen 170 . Optical fiber 150 may be advanced through fiber lumen 170 to align optical fiber 150 with light directing member 160 . In some embodiments, an optical fiber is used to uniformly illuminate the facets 166 of the light directing member 160 and to allow illumination in the central hole for longitudinal illumination and return. The central axis of 150 may be aligned (aligned) with the central axis of light directing member 160 . For example, fiber lumen 170 may extend along the central axis of fiber alignment member 168 to center optical fiber 150 in light directing member 160 . The position of the fibers in the fiber alignment member 168 is optimized to provide the desired light distribution between the central hole of the light directing member 160 and the aperture 154 to maximize tissue fluorescence for the intended ablation application. obtain.

A fiber alignment member 168 may be inserted into the distal end member 148, as shown in FIGS. 6C and 6D. Optical fiber 150 passes through fiber lumen 17 of fiber alignment member 168 .
Any desired orientation and orientation with respect to the light directing member 160 may be achieved when advancing through zero.

Referring again to FIG. 6B, in some embodiments, fiber alignment member 168 may comprise one or more notches 172 and one or more ports 174. As shown in FIG. In this manner, when fiber alignment member 168 is inserted into distal end 146 of catheter 140 , notch 172 and port 174 allow instruments and substances (e.g., irrigation fluids and ablation agents) to distal end member 148 . electrode wiring, etc.) can be passed through.

7A and 7B, light directing member 160 may include keying members 174 that help align facets 166 of light directing member 160 with one or more openings 154 . The facet angle of the light directing member 160 may be aligned with the opening 154 of the distal end member 148 . If these are mismatched, the optical path can become inefficient. To ensure this alignment, in some embodiments, light directing member 160 and distal end member 148 have symmetrical keying features so that alignment between facet 166 and aperture is deterministic. Once in place, various techniques may be used to secure light directing member 160 to distal end member 148 .

8A and 8B, in some embodiments, light directing member 160 may comprise a single faceted mirror capable of emitting and receiving light in only one direction at a time. In some embodiments, such light directing member 160 may be rotatable relative to catheter 140 to align opening 154 in side wall 156 with a target site. There are many ways to provide a rotating mirror, including but not limited to a hydraulic turbine mechanism with a torque mechanism on the handle 147 of the catheter 140 connected to the light directing mirror.
Referring to FIG. 8B, in some embodiments the fixed mirror may be given a conical shape different from a facet shape. Figures 8C and 8D show another embodiment of a light directing member 160 with six facets.

FIG. 9 shows a catheter 140 of the present disclosure positioned toward an observer. When a vial of solution that fluoresces at the same wavelength as NADH is held next to catheter 140, a light path emanating radially from distal end member 148 interacts with the vial of solution. Distal end member 148
are invisible due to the lack of fluorescence.

As noted above, system 100 may also include an irrigation system 170 . In some embodiments, the irrigation system 170 pumps saline into the catheter to cool the tip electrode during the ablation procedure. This can lead to steam popping and charring (i.e. clots that stick to the tip and can later fall off and cause a thrombolytic event).
can help prevent the formation of In the proposed optical system, the fluid flow can remove blood from the opening of the distal end member 148 that would otherwise absorb the illumination light.

The irrigation system 170 may be connected to one or more openings in the distal end member 148, for example, to irrigate the openings with fluid, to irrigate the tip (distal end), among many other possible uses. removing blood, tissue-electrode interface
can be used to cool and prevent thrombus formation. In some embodiments, the irrigation fluid is maintained at a positive pressure relative to the pressure outside the catheter to continuously clean one or more openings 154 .

Referring to FIG. 10, operation of the system 100 of the present disclosure is shown. First, catheter 140 is inserted into an area of heart tissue suffering from atrial fibrillation, such as the pulmonary vein/left atrial junction or other area of the heart (step 1010). Blood may be removed from the field of view by, for example, irrigation. The diseased area (affected area) may be illuminated with UV light reflected from the light directing member 160 (step 1015). Tissue within the irradiation area may be ablated before, after, or during irradiation (step 1020). Any of point-to-point RF ablation, cryoablation, laser or other known ablation procedures can be performed using the system of the present disclosure.

Still referring to FIG. 10, the illuminated area may be imaged using a light directing member that receives light from the tissue and directs it into the optical fiber (step 1025). This optical fiber can transmit the light to the spectrometer. In some embodiments, the methods of the present disclosure rely on imaging the fluorescence emission of NADH, the reduced form of nicotinamide adenine dinucleotide (NAD+). NAD+ is a coenzyme and plays an important role in the aerobic metabolic redox reactions of all living cells. This NAD+ works as an oxidant by accepting electrons from the citric acid cycle (tricarboxylic acid cycle) that occurs in mitochondria. This process thus reduces NAD+ to NADH. NADH and NAD+ are most abundant in the respiratory unit of cells (mitochondrion), but are also present in the cytoplasm. N.
ADH is an electron and proton donor in mitochondria, regulates cell metabolism, and participates in many biological processes, including DNA repair and transcription.

By measuring UV-induced tissue fluorescence, it is possible to know the biochemical state of the tissue. NADH fluorescence has been investigated for its use in monitoring cell metabolic activity and cell death. In several in vitro and in vivo studies,
The possibility of using NADH fluorescence intensity as an endogenous biomarker to monitor cell death (either apoptosis or necrosis) has been investigated. When NADH is released from the mitochondria of damaged cells or converted to its oxidized form (NAD+), its fluorescence is significantly reduced, which is very useful in distinguishing between healthy and damaged tissue. NAD
H can accumulate intracellularly during ischemic conditions when oxygen is unavailable, increasing fluorescence intensity. However, in the case of dead cells, any presence of NADH disappears. The following table summarizes the relative intensities of various states based on NADH fluorescence.

Still referring to FIG. 10, both NAD+ and NADH absorb UV light very readily, but NADH autofluoresces in response to UV excitation, whereas NAD+ does not. N.
ADH has a UV excitation peak at about 340-360 nm and an emission peak at about 460 nm. In some embodiments, methods of the present disclosure may use excitation wavelengths between about 330 nm and about 370 nm. Therefore, with the use of appropriate instruments, it is possible to image emission wavelengths as a real-time observation of hypoxic and necrotic tissue within the region of interest. Further, in some embodiments, relative distance (
relative metric) can be captured.

Under hypoxic conditions, oxygen levels drop. The intensity of the subsequent fNADH release signal increases, which may indicate an excess of mitochondrial NADH. If hypoxia is left unchecked, the death of the affected cells along with their mitochondria will eventually result in maximal attenuation of the signal. High contrast of NADH levels can be used to discriminate around terminally damaged ablated tissue.

NADH can be excited by UV light from a light source such as a UV laser to initiate fluorescence imaging. NADH in tissue specimens absorbs the excitation wavelength of light and emits longer wavelength light. The emitted light is collected and returned to the spectrometer for display of the imaged illuminated area.
) may be generated on the display (step 1030). This display is used to distinguish between ablated and non-ablated tissue within the imaging region based on the amount of NADH fluorescence (step 1035). For example, a completely ablated site may appear as a completely dark area due to the absence of fluorescence. Thus, the ablated region may appear significantly darker when compared to the surrounding non-ablated myocardium, which appears brighter. This feature provides significant contrast to healthy tissue, and additional contrast at the border regions between ablated and healthy tissue, thereby enhancing the ability to detect the ablated region. can. This border region is edematous and ischemic tissue, where NADH fluorescence appears bright white on imaging. The border region takes on the shape (makes the appearance) of a halo around the ablated central tissue.

The process can then be repeated by returning to the ablation step to ablate additional tissue, if desired. Although FIG. 10 shows the steps being performed sequentially, it should be appreciated that many of the steps may be performed at the same time, near the same time, or in a different order than that shown in FIG. For example, ablation, imaging, and display can occur simultaneously, and identification of ablated and non-ablated tissue can occur while tissue is being ablated.

In some embodiments, the disclosed system comprises a catheter, a light source, and a light meter. In some embodiments, the system further comprises a photodetection system having a photodetection fiber. The photodetection system is independent or unaffected by electrical or RF energy noise. In some embodiments, the photo-detecting fiber is not electrically conductive and the RF energy does not produce electromagnetic energy of interest to the system.

In some embodiments, the system is configured (adapted) to optically probe the catheter environment (the circumstances surrounding the catheter) in a biological system. In some embodiments, the system is configured to optically probe the catheter environment in real-time with NADH fluorescence to determine or assess one or more of full or partial immersion of the electrode in the blood pool. be. For example, the optics can detect by inference that the catheter tip is fully or partially immersed in a blood pool. This is because, unlike tissue or vasculature, which returns a positive optical signature, blood completely absorbs illumination light at this wavelength, resulting in a zero optical signature. This feature of complete absorption provides optical isolation and thus noise isolation. The instrument can use this situation for optical calibration and to remove accidental optical signatures introduced by the catheter itself. Additionally, the system provides qualitative and/or quantitative contact assessment between the catheter tip and tissue, qualitative and/or quantitative assessment of catheter contact stability, real-time ablation lesion formation, and ablation lesion progression monitoring. , determining when the injury should be terminated, identifying areas of edema that are likely to occur around the ablation site and may be associated with incomplete ablation injury, determining the depth of the ablation injury, identifying the cross-sectional area of the injury, temperature of the injury. identification of steam generation, or changes in another physiological parameter to predict the onset of steam pop (steam pop), formation of char on the tip electrode during or after the formation of an ablation lesion. , detection of ischemia, detection of ischemia level (degree of ischemia), assessment of ablation damage after injury formation, edematous area for reablation when the edematous area includes electrically shocked myocardium and mapping the location of previously ablated tissue by distinguishing metabolically active from metabolically inactive tissue.

In some embodiments, the system is configured to optically probe tissue parameters of NADH fluorescence (fNADH).

In some embodiments, the system is configured to optically probe the tissue, where the system analyzes parameters including the metabolic state of the tissue and the histology of the tissue.

In some embodiments, the system irradiates (illuminates) the tissue at one wavelength
, and illumination produces several optical responses. In some embodiments, this optical response includes fluorescence emission of NADH contained in the myocardium, if the myocardium is in a healthy metabolic state. In some embodiments, other tissues, such as collagen or elastin, fluoresce at different wavelengths, and the system uses measurement of this information to determine the composition of the tissue (i.e., collagen or elastin) in contact with the catheter. decide. In some embodiments, the tissue organization (composition) is myocardium, muscle, myocardial structures (valves, vasculature, etc.), and
Contains fibrous or anatomical components. In some embodiments, the tissue architecture (composition) comprises collagen, elastin, and fibrous or supportive structures.

In some embodiments, a catheter of the present disclosure comprises a catheter body, a tip electrode, and one
It has one or more sense electrodes (detection electrodes). In some embodiments, the catheter further comprises one or more zones with different flexibilities. The section is associated with a deflection mechanism configured to allow the distal portion of the catheter to be bent to facilitate navigation by the physician. In some embodiments, the flexible section is located in the distal portion of the catheter while the body of the catheter remains relatively stiff for pushability. In some embodiments, the body of the catheter body is flexible to allow the physician to use a robotic system for catheter guidance. In some embodiments, the catheter is flexible and can be manipulated manually or robotically within the catheter sheath.

In some embodiments, the catheter further comprises a deflection mechanism configured to deflect the catheter tip for guidance. In some embodiments, the deflection mechanism comprises one or more puller wires. The wires are manipulated with the catheter handle to deflect or bend the distal portion of the catheter in one or more directions. In some embodiments, the catheter further comprises a temperature sensor integral with the distal end member of the electrode. In some embodiments, the catheter further comprises one or more ultrasound transducers positioned at the distal portion of the catheter, preferably at the tip of the distal electrode. The ultrasound transducer is configured to assess (measure) tissue thickness under or adjacent to the catheter tip. In some embodiments, the catheter comprises multiple transducers. The transducer is configured to provide depth information covering situations where the catheter tip is relatively perpendicular to or parallel to the myocardium.

In some embodiments, the catheter further comprises irrigation means. The irrigation means is for removing blood from the catheter tip by flushing the catheter opening with an irrigation fluid, for cooling the tissue-electrode interface (the contact area between the tissue and the electrode), and for preventing thrombus formation. and to spread the RF energy over a larger area of tissue, thereby creating a larger lesion than a non-irrigating catheter. In some embodiments, the irrigation fluid is maintained at a positive pressure within the catheter tip relative to the outside of the catheter tip, suitable for continuous flushing of the orifice.

In some embodiments, the catheter includes electrical, magnetic, or electromagnetic position or navigation sensors (guidance sensors) for locating and guiding the catheter. In some embodiments, the sensor is configured to locate the tip of the catheter within a navigation system of one of several catheter or system manufacturers. Sensors exchange energy from a source position and can calculate position by triangulation or other means. In some embodiments, the catheter comprises two or more sensors or transducers configured to render (display) the position of the catheter body and the curvature of the catheter body on the display of the navigation system.

In some embodiments, a catheter configured to ablate tissue comprises
It comprises a catheter body and a tip electrode configured to ablate tissue. In some embodiments, the catheter further comprises at least one optical waveguide configured to deliver optical energy to tissue and one or more optical waveguides configured to receive optical energy from tissue. . In some embodiments, the catheter further comprises a single optical waveguide configured to deliver optical energy to tissue and receive optical energy from tissue.

In some embodiments, the catheter is suitable for ablative energy, wherein the ablative energy is RF energy, cryogenic energy, lasers, chemicals, electroporation, high intensity focused ultrasound or ultrasound. one or more of sound waves and microwaves.

In some embodiments, the tip of the catheter includes a first electrode configured to sense electrical activity in tissue and a second electrode configured to send or transmit ablation energy or chemicals. two electrodes, a light directing member that simultaneously directs light in one or more directions, one or more apertures for transmitting and receiving light energy, and one or more apertures through which irrigation fluid flows from the tip. and one or more openings configured to transmit and receive light while allowing irrigation fluid to flow from the tip. In some embodiments, the tip of the catheter comprises a conductive material adapted (suitable for sensing) to enable the first electrode to sense electrical activity in tissue in contact with the catheter. In some embodiments, the tip further comprises an electrode configured to send or transmit ablation energy or chemical energy. In some embodiments, the tip is configured to transmit RF energy to adjacent tissue. In some embodiments, the tip comprises an optically transparent material that allows transmission of laser ablation energy to adjacent tissue.
In some embodiments, the tip comprises a plurality of pores configured to deliver chemicals used to alter tissue cells, or tissue cells in close proximity to the tip. In some embodiments, the opening for transmitting and receiving light is at the distal tip (distal end member). In some embodiments, the tip comprises an additional plurality of holes configured to fluidly cool the tip during application of ablation energy.

In some embodiments, the tip enables directed light energy to irradiate tissue (directed light energy illuminates tissue) and light energy to return from tissue to the catheter. It further comprises at least one opening configured to.
In some embodiments, the tip comprises at least one opening in the distal tip (distal end member) for illuminating tissue along the longitudinal axis of the catheter. In some embodiments, a central lumen that allows for longitudinal guidance of a portion of the light
Light energy is directed in a manner dependent on the light directing member having a lumen. In some embodiments, the tip further comprises at least one opening in the distal tip (distal end member) for illuminating tissue radially axially relative to the catheter. In some embodiments, the tip is configured to direct light by splitting a primary light source into specific multiple beams using a light directing member.

In some embodiments, the primary light source is a laser adapted to send a light beam to the light directing member ahead of the optical fiber, ensuring that the light beam illuminates structures adjacent to the catheter ( illuminating) in one or more directions, including straight ahead (advance direction) relative to the tip. In some embodiments, the illuminated structure transmits light energy back to the catheter tip and light directing member, and the return light is then reflected down the fiber to the spectrometer.

In some embodiments, the tip is configured to direct light energy independently of polishing the interior of the illumination cavity. In some embodiments, directing light energy comprises:
It does not depend on the use of inner walls of the illumination cavity.

In some embodiments, one catheter configured to support fNADH
Equipped with one or more ultrasonic transducers. In some embodiments, the catheter is configured to measure the wall thickness of the region of interest. In some embodiments, the catheter is configured to assess tissue metabolic status through wall thickness. In some embodiments, the catheter further comprises an ultrasound transducer configured to assess the metabolic state of the myocardium during application of the RF energy and configured to measure the thickness of the heart wall. In some embodiments, the catheter is configured to identify metabolically active tissue to identify electrical gaps in the lesion.

In some embodiments, the catheter comprises a light directing element configured to simultaneously transmit light in one or more radial and axial directions. In some embodiments, the catheter further comprises a separate or modular element of a tip electrode, with the light directing member incorporated at the tip of the electrode. In some embodiments, the light directing member has a centrally located lumen for the axial passage of light. In some embodiments, the light directing member is adapted to facilitate alignment of the facets of the light directing member with openings in the catheter tip that allow transmission of light energy. In some embodiments, the light directing member is incorporated into the catheter tip by snap fitting, welding, soldering, or gluing at a fixed location within the catheter tip.

In some embodiments, the light directing member is adapted to facilitate precise alignment of one or more reflective facets with one or more light ports at the tip of the catheter. In some embodiments, the light directing member is a separate element disposed within the catheter tip, the element configured to provide a light path through said tip along the longitudinal axis of the catheter. be done. In some embodiments, a light directing member protrudes from the tip and may be welded to the distal side of the tip such that the weld does not interfere with or damage the reflective surface of the light directing member. In some embodiments, the light directing member comprises polished stainless steel. In some embodiments, the light directing member is platinum or a platinum alloy, the same material as the tip, a material with a reflective surface that can reflect or split light, or fluoresce when illuminated at about 310 nm to about 370 nm. Including materials that do not In some embodiments, the light directing member is larger than any opening in the tip electrode and thus can never exit the opening.

In some embodiments, the light directing member can be optimized to provide an optimum number of facets and an optimum optical path for efficiency. This feature can be a trade-off for the desired radiation coverage. For example, in connection with tissue contact with a distal tip (distal member) parallel to the myocardial surface, the radial coverage is such that when said tip is parallel to the heart tissue, the distal tip (distal member) ) can be designed such that at least one opening in the side wall of the heart muscle is directed toward the myocardium. Similarly, when the catheter tip is approximately perpendicular to the myocardial surface, the distal tip (distal end member)
The transmission and reception of light can be reliably realized by the opening in the front wall of the . In some embodiments, the light directing member is provided with 3-4 facets.

In some embodiments, the catheter of the present disclosure comprises the following components along with the catheter body. The catheter includes a distal end member (distal tip) disposed at the distal end of the catheter body and defining a light chamber, the distal end member exchanging light energy between the light chamber and tissue. has one or more openings for The catheter includes a light directing member disposed within the light chamber, the light directing member directing light energy to tissue through one or more openings in the distal end member, and Configured to direct light energy from tissue. In some embodiments, the catheter comprises one or more optical waveguides that extend into and transmit light to and from the optical chamber. In some embodiments, the catheter has a light directing member and the one or more openings are configured to illuminate tissue radially and axially. In some embodiments, the catheter has a distal end member with a domed front wall and straight sidewalls. In some embodiments, the catheter has one or more openings disposed along the sidewall of the distal end member. In some embodiments, the catheter is circumferentially disposed along the distal end member 1
having one or more openings. In some embodiments, the catheter has one or more openings provided in double rows (multiple rows) along the sidewall of the distal end member. In some embodiments, the catheter has a distal end member comprising a tissue ablation electrode.
In some embodiments, the catheter has a light directing member configured to radially direct light from one or more openings. In some embodiments, the catheter has a light directing member comprising a plurality of facets. In some embodiments, the catheter has a light directing member comprising a plurality of equally spaced facets. In some embodiments, the catheter has a light directing member configured with a plurality of facets, the number of facets matching the number of openings along the sidewall of the distal end member. In some embodiments, the catheter has a light directing member shaped (shaped) to reflect light energy at an angle relative to the longitudinal axis of the catheter.

In some embodiments, the catheter has a light directing member comprising a single-faceted mirror. In some embodiments, the catheter has a light directing member that is rotatable relative to the light chamber. In some embodiments, the catheter is
A light directing member comprising one or more through-holes, and a distal end member comprising one or more openings disposed in a front wall of the distal end member, through which the light is directed. It can pass longitudinally through one or more openings in the light guide member and the front wall.

The above disclosure has been set forth merely to illustrate various non-limiting embodiments of the present disclosure and is not intended to be limiting. Since modifications of the disclosed embodiments incorporating the spirit and spirit of the disclosure may occur to persons skilled in the art, the embodiments disclosed herein come within the scope of the appended claims and equivalents thereof. should be construed as inclusive.
The claims as originally filed were as follows.
[Claim 1]
A catheter for visualizing ablated tissue, comprising:
a catheter body;
a distal end member disposed at the distal end of the catheter body and defining an irradiation cavity;
a light directing member disposed within the illumination cavity;
with
the distal end member has one or more openings for exchanging light energy between the illumination cavity and tissue;
the light directing member is configured to direct light energy to and from tissue through one or more openings in the distal end member;
catheter.
[Claim 2]
2. The catheter of claim 1, further comprising one or more optical fibers extending into and transmitting light to and from the illumination cavity.
[Claim 3]
3. The distal end member further comprises a fiber alignment member, the fiber alignment member configured to align the one or more optical fibers with a central axis of the light directing member. The catheter described in .
[Claim 4]
A catheter of claim 1, wherein the light directing member and the one or more openings are configured to illuminate tissue radially and axially relative to the longitudinal axis of the catheter.
[Claim 5]
The one or more openings are disposed along the sidewall of the distal end member, and the light directing member directs light through the one or more openings at an angle to the longitudinal axis of the catheter. 2. The catheter of claim 1, configured to direct energy.
[Claim 6]
The light directing member comprises one or more through-holes and the distal end member comprises one or more openings disposed in the front wall of the distal end member such that light is directed through the light directing member and through 6. The catheter of claim 5, capable of longitudinally passing through one or more openings in the front wall.
[Claim 7]
A catheter of claim 5, wherein the light directing member is aligned with the one or more openings to reflect light only through the one or more openings.
[Claim 8]
The one or more openings are circumferentially disposed along the distal end member and are equidistantly spaced from one another, and the light directing members are aligned with the one or more openings. 2. The catheter of claim 1, comprising evenly spaced facets of .
[Claim 9]
The distal end member is configured to deliver ablation energy to tissue, wherein the ablation energy includes radio frequency (RF) energy, microwave energy, electrical energy, electromagnetic energy, cryogenic energy, laser energy, ultrasonic energy, The catheter of any one of claims 1-8, selected from the group consisting of acoustic energy, chemical energy, thermal energy and combinations thereof.
[Claim 10]
The catheter of any one of claims 1-8, further comprising an ultrasound transducer.
[Claim 11]
The catheter of any one of claims 1-8, further comprising a position or navigation sensor.
[Claim 12]
A system for visualizing ablated tissue, comprising:
a catheter;
a light source;
a light measuring instrument;
one or more optical fibers in communication with the light source and the light measuring device;
with
The catheter is
a catheter body;
a distal end member disposed at the distal end of the catheter body and defining an irradiation cavity;
a light directing member disposed within the illumination cavity;
with
the distal end member has one or more openings for exchanging light energy between the illumination cavity and tissue;
the light directing member is configured to direct light energy to and from tissue through one or more openings in the distal end member;
the one or more optical fibers extend through the catheter body and into the illumination cavity of the distal end member;
the one or more optical fibers configured to direct light energy from the light source to the light directing member to illuminate tissue outside the distal end member;
wherein the one or more optical fibers are configured to relay light energy reflected from tissue to the light meter;
system.
[Claim 13]
13. The system of claim 12, wherein the one or more optical fibers comprise fiber bundles or single fibers.
[Claim 14]
14. The distal end member further comprises a fiber alignment member, the fiber alignment member configured to align the one or more optical fibers with a central axis of the light directing member. The system described in .
[Claim 15]
13. The system of claim 12, wherein the light directing member and the one or more openings are configured to illuminate tissue radially and axially relative to the longitudinal axis of the catheter.
[Claim 16]
The one or more openings are disposed along the sidewall of the distal end member, and the light directing member directs light through the one or more openings at an angle to the longitudinal axis of the catheter. 13. The system of claim 12, configured to direct energy.
[Claim 17]
The light directing member comprises one or more through-holes and the distal end member comprises one or more openings disposed in the front wall of the distal end member such that light is directed through the light directing member and through 17. The system of claim 16, capable of longitudinally passing through one or more openings in the front wall.
[Claim 18]
17. The system of claim 16, wherein the light directing member is aligned with the one or more openings to reflect light only through the one or more openings.
[Claim 19]
The one or more openings are circumferentially disposed along the distal end member and are equidistantly spaced from one another, and the light directing members are aligned with the one or more openings. 13. The system of claim 12, comprising evenly spaced facets of .
[Claim 20]
The distal end member is configured to deliver ablation energy to tissue, wherein the ablation energy includes radio frequency (RF) energy, microwave energy, electrical energy, electromagnetic energy, cryogenic energy, laser energy, ultrasonic energy, 20. The system of any one of claims 12-19, wherein the system is selected from the group consisting of acoustic energy, chemical energy, thermal energy and combinations thereof.
[Claim 21]
The system of any one of claims 12-19, wherein the catheter further comprises an ultrasound transducer.
[Claim 22]
The system of any one of claims 12-19, wherein the catheter further comprises a position or navigation sensor.
[Claim 23]
A method of visualizing ablated tissue, comprising:
a catheter body;
A distal end member disposed at the distal end of the catheter body and defining an illumination cavity, the distal end member having one or more openings for exchanging light between the illumination cavity and tissue. a proximal member;
A light directing member disposed within the illumination cavity to direct light to and from tissue through one or more openings in the distal end member. the light directing member configured to:
advancing a catheter comprising a to cardiac tissue requiring ablation;
one or more openings in the distal end member of the catheter for exciting nicotinamide adenine dinucleotide hydrogens (NADH) in regions of cardiac tissue, including ablated and non-ablated cardiac tissue; directing light into the light directing member via
collecting light reflected from cardiac tissue through the one or more apertures and directing the collected light to a light meter;
imaging the region of cardiac tissue to detect NADH fluorescence in the region of cardiac tissue;
generating a representation of the imaged and illuminated cardiac tissue;
including
the display shows the ablated heart tissue as exhibiting less fluorescence than the non-ablated heart tissue;
Method.
[Claim 24]
24. The method of claim 23, further comprising ablating tissue with the distal end member prior to imaging the tissue.
[Claim 25]
25. The method of claim 24, further comprising ablating another non-ablated heart tissue identified by distinguishing between the ablated heart tissue and the non-ablated heart tissue based on the amount of fluorescence. described method.
[Claim 26]
24. The method of claim 23, wherein the light directing member and the one or more openings are configured to illuminate cardiac tissue radially and axially relative to the longitudinal axis of the catheter.
[Claim 27]
24. The method of claim 23, further comprising one or more optical fibers extending into and transmitting light to and from the illumination cavity.
[Claim 28]
28. The distal end member further comprises a fiber alignment member, the fiber alignment member configured to align the one or more optical fibers with a central axis of the light directing member. The method described in .
[Claim 29]
24. The method of claim 23, wherein the light directing member and the one or more openings are configured to illuminate tissue radially and axially relative to the longitudinal axis of the catheter.
[Claim 30]
The one or more openings are disposed along the sidewall of the distal end member, and the light directing member directs light through the one or more openings at an angle to the longitudinal axis of the catheter. 24. The method of claim 23, configured to direct energy.
[Claim 31]
The light directing member comprises one or more through-holes and the distal end member comprises one or more openings disposed in the front wall of the distal end member such that light is directed through the light directing member and through 31. The method of claim 30, wherein one or more openings in the front wall can be longitudinally passed.
[Claim 32]
31. The method of Claim 30, wherein the light directing member is aligned with the one or more openings to reflect light only through the one or more openings.
[Claim 33]
The one or more openings are circumferentially disposed along the distal end member and are equidistantly spaced from one another, and the light directing members are aligned with the one or more openings. 24. The method of claim 23, comprising evenly spaced facets of .
[Claim 34]
The distal end member is configured to deliver ablation energy to tissue, wherein the ablation energy includes radio frequency (RF) energy, microwave energy, electrical energy, electromagnetic energy, cryogenic energy, laser energy, ultrasonic energy, 34. The method of any one of claims 23-33, wherein the energy is selected from the group consisting of acoustic energy, chemical energy, thermal energy and combinations thereof.
[Claim 35]
34. The method of any one of claims 23-33, further comprising an ultrasonic transducer.
[Claim 36]
A method according to any one of claims 23 to 33, further comprising a position sensor or navigation sensor.
[Claim 37]
A system for visualizing ablated tissue, comprising:
a catheter;
an ablation therapy system;
a visualization system;
an irrigation system;
an ultrasound system for ultrasonically evaluating tissue;
a navigation system for locating and guiding the catheter;
with
The catheter is
a catheter body;
a distal end member disposed at the distal end of the catheter body and defining an irradiation cavity;
a light directing member disposed within the illumination cavity;
with
the distal end member configured to deliver ablation energy to tissue;
the distal end member has one or more openings for exchanging light energy between the illumination cavity and tissue;
the light directing member is configured to direct light energy to and from tissue through one or more openings in the distal end member;
the catheter further comprises one or more ultrasonic transducers and one or more electromagnetic position sensors;
the ablation treatment system in communication with the distal end member for delivering the ablation energy to tissue;
The visualization system includes:
a light source;
a light measuring instrument;
one or more optical fibers in communication with the light source and the light measuring device;
with
the one or more optical fibers extend through the catheter body and into the illumination cavity of the distal end member;
the one or more optical fibers configured to exchange optical energy with the illumination cavity;
the irrigation system is for cleaning the one or more openings;
the ultrasound system is in communication with the one or more ultrasound transducers;
the navigation system is in communication with the one or more electromagnetic position sensors;
system.
[Claim 38]
The ablative energy is selected from the group consisting of radio frequency (RF) energy, microwave energy, electrical energy, electromagnetic energy, cryogenic energy, laser energy, ultrasonic energy, acoustic energy, chemical energy, thermal energy and combinations thereof. 38. The system of claim 37.

Claims (17)

A catheter for visualizing ablated tissue, comprising:
a catheter body;
A distal end member disposed at the distal end of the catheter body and defining an illumination cavity, the distal end member having one or more openings for exchanging light energy between the illumination cavity and tissue. a distal end member;
a plurality of optical fibers extending through the catheter body and into the illumination cavity to direct optical energy into tissue through one or more openings in the distal end member; the plurality of optical fibers configured to direct light energy from tissue;
a catheter. 2. The distal end member of claim 1 , further comprising a fiber alignment member, the fiber alignment member configured to align the plurality of optical fibers with a central axis of a light directing member. catheter. A catheter of claim 1, wherein the one or more openings are configured to illuminate tissue radially and axially relative to the longitudinal axis of the catheter. 2. The method of claim 1, further comprising a light directing member, said light directing member configured to direct light energy through said one or more openings at an angle relative to a longitudinal axis of said catheter. Catheter as described. The light directing member comprises one or more through-holes and the distal end member comprises one or more openings disposed in the front wall of the distal end member such that light is directed through the light directing member and through 5. The catheter of claim 4 , capable of longitudinally passing through one or more openings in the front wall. 5. The catheter of claim 4 , wherein the light directing member is aligned with the one or more openings to reflect light only through the one or more openings. The one or more openings are circumferentially disposed along the distal end member and are equidistantly spaced from each other, and the light directing members are aligned with the one or more openings. 5. The catheter of claim 4 , comprising evenly spaced facets of . The distal end member is configured to deliver ablation energy to tissue, wherein the ablation energy includes radio frequency (RF) energy, microwave energy, electroporation energy, electrical energy, electromagnetic energy, cryogenic energy, laser energy. , ultrasonic energy, acoustic energy, chemical energy, thermal energy, and combinations thereof. A catheter of claim 1, further comprising an ultrasound transducer. A system for visualizing ablated tissue, comprising:
a catheter comprising a catheter body, a distal end member, and a plurality of optical fibers;
a light source in communication with the plurality of optical fibers;
an optical measuring instrument connected to the plurality of optical fibers;
with
the plurality of optical fibers extending through the catheter body;
the distal end member is disposed at the distal end of the catheter body and configured to receive the plurality of optical fibers;
The distal end member has the one or more openings for exchanging optical energy between the plurality of optical fibers and tissue through the one or more openings of the distal end member. ,
the plurality of optical fibers configured to direct light energy to and from tissue through the one or more openings in the distal end member; system. 11. The distal end member of Claim 10 , further comprising a fiber alignment member, said fiber alignment member configured to align said plurality of optical fibers with a central axis of a light directing member. system. 11. The system of claim 10 , wherein the one or more openings are configured to illuminate tissue radially and axially relative to the longitudinal axis of the catheter. 11. The embodiment of claim 10 , further comprising a light directing member, said light directing member configured to direct light energy through said one or more openings at an angle relative to a longitudinal axis of said catheter. System as described. The light directing member comprises one or more through-holes and the distal end member comprises one or more openings disposed in the front wall of the distal end member such that light is directed through the light directing member and through 14. The system of claim 13 , capable of longitudinally passing through one or more openings in the front wall. The one or more openings are circumferentially disposed along the distal end member and are equidistantly spaced from each other, and the light directing members are aligned with the one or more openings. 14. The system of claim 13 , comprising equally spaced facets of . 11. The system of Claim 10 , further comprising an ultrasonic transducer. Further comprising an ablation energy source in communication with the distal end member for supplying ablation energy to tissue, the ablation energy being radio frequency (RF) energy, microwave energy, electrical energy, electroporation energy, electromagnetic energy. 11. The system of claim 10 , selected from the group consisting of: , cryogenic energy, laser energy, ultrasonic energy, acoustic energy, chemical energy, thermal energy and combinations thereof.

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